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Ending the HIV Epidemic: An All-facility Intervention for Patient and Healthcare Staff Well-being

Ending the HIV Epidemic: An All-facility Intervention for Patient and Healthcare Staff Well-being

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05785169
Enrollment
1000
Registered
2023-03-27
Start date
2025-01-27
Completion date
2028-04-01
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Stigma, Well-Being, Psychological

Brief summary

The scope of this study is to engage Ryan White HIV/AIDS Program (RWHAP) funded organizations in the South/East US to co-develop context-responsive programs utilizing evidence-informed interventions to reduce stigma against living with HIV (PLH) who have difficulties accessing and remaining engaged in life-saving treatment. Five RWHAP clinics will be selected for this trial. Clinic members will participate in interactive trainings to raise awareness of and reduce stigma, from the clinic policy level to individual attitudes. Clinic members and select patients will complete self-administered surveys every 6 months over 24 months.

Detailed description

The scope of this study is to engage HIV care clinics in the United States to co-develop context-responsive programs utilizing evidence-informed interventions to reduce processes and practices perceived as stigmatizing by people living with HIV who have difficulties accessing and remaining engaged in life-saving treatment. HIV-related stigma in a clinical setting directly impacts access to and uptake of healthcare, including engagement in HIV care services. The proposed intervention draws on the evidence-based Health Policy Plus (HP+) 'total' facility HIV stigma-reduction intervention that focuses on the clinics' organizational and interpersonal levels to strengthen patient care and engagement in services, and staff wellbeing. We will conduct an implementation trial of our HIV stigma-reduction intervention. Clinics will receive training to support them in 1) identifying/creating organizational-level policies and practices (e.g., clear understanding of what practices can be experienced as stigmatizing) to reduce HIV stigma, and 2) deliver participatory trainings to all staff (e.g., building awareness of the impact of patient perceptions and experiences of HIV-related stigma on health). In Aim 3, we will evaluate outcomes, including at the organization (primary outcome of Stigma Reduction Index - ratings of mission/vision statements, policies around HIV stigma, comfort level in clinics), interpersonal (secondary outcomes of provider/staff attitudes; behavior), and individual patient and/or staff (tertiary outcomes of clinic-level HIV indicators, reports of HIV care practices that can be experienced as stigmatizing, anxiety, depression, and stress) levels. Assessments will take place every 6 months. The intervention will generate strategies to improve the wellbeing of the healthcare workforce. Ultimately, the study will produce implementation lessons on how to effectuate clinical practice changes to increase access to effective HIV treatment, as well as the wellbeing of the healthcare workforce.

Interventions

BEHAVIORALAll-facility Training

The HP+ curriculum includes total-site training and co-facilitation via participatory modules. To change clinic culture, a multi-level approach that includes the whole facility and reaches all parties is required. The intervention aims to modify top-down mechanisms of influence. The training is modeled on these principles and supports the development of multiple stigma-reduction strategies to improve patient and staff wellbeing.

Sponsors

Columbia University
Lead SponsorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH
Rutgers University
CollaboratorOTHER
Florida State University
CollaboratorOTHER
RTI International
CollaboratorOTHER
Duke University
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The intervention will be implemented across five clinics simultaneously across six months post-baseline.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Selected Ryan White Clinics. Selection based on the following: First, clinic leaders will complete a 15-min Site Characteristics Survey, assessing suitability for participation and clinic comparability. Staff and leadership at Ryan White clinics will next complete an anonymous 15-minute Eligibility Survey. Within each clinic, both clinic staff and patients will be invited to participate.

Exclusion criteria

* Non-Ryan White Clinics * Clinics not located in the geographical area of interest * Clinics that are not interested in participating

Design outcomes

Primary

MeasureTime frameDescription
Change in Stigma Index (SI)Baseline, 6, 12, 18, and 24 monthsThe SI is a rating of clinic mission/vision statements, the anti-stigma policy, and the clinic context. A change in the mean score of SI post-intervention implementation will be measured. Scores range from 0-100, with a higher score indicating increased anti-stigma policies and procedures.

Secondary

MeasureTime frameDescription
Change in Cultural Humility ScoreBaseline, 6, 12, 18, and 24 monthsCultural humility as measured by the adapted Trauma-Informed, Resilience-Oriented Care (TI-ROC) Cultural Humility Scale, which assess staff's perceptions of colleagues and clinic context. Scores range from 12-60. The negative items are reverse coded such that higher scores indicate higher cultural humility indicating better outcomes.

Countries

United States

Contacts

CONTACTCorina T Lelutiu-Weinberger, PhD
cl4265@cumc.columbia.edu212-305-5756
CONTACTFelicia A Browne, ScD
fbrowne@rti.org919-541-6596
PRINCIPAL_INVESTIGATORCorina Lelutiu-Weinberger, PhD

Columbia University

PRINCIPAL_INVESTIGATORFelicia A Browne, ScD

RTI International

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026